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RECRUITINGPhase 4INTERVENTIONAL

BenRalizumab Effect on Airway Remodeling in Severe asTHma

BenRalizumab Effect on Airway Remodeling in Severe Eosinophilic asTHmatics

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment. Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis. Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?

Who May Be Eligible (Plain English)

Who May Qualify: - Written willing to sign a consent form must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation willing to sign a consent form form): Able to give written willing to sign a consent form prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. - Confirmed severe asthma diagnosis and treatment requirements according to American Thoracic Society(ATS)/European Respiratory Society (ERS) guidelines and Global Initiative for Asthma (GINA) 2023. - Blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months. - Patients with history ≥ 1 exacerbation the previous year under the treatment of high dose of inhaled corticosteroid(ICS)+LABA±LAMA or receiving oral/systemic corticosteroids at least 3 days. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days. - Meet requirements for biologic therapy with Benralizumab. Who Should NOT Join This Trial: - Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit. - Prior use of other biologics that has potential to interfere/ affect disease progression. - Pregnant or nursing women, or women of child-bearing potential. - History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician. - Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Written informed consent must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation informed consent form): Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials. * Confirmed severe asthma diagnosis and treatment requirements according to American Thoracic Society(ATS)/European Respiratory Society (ERS) guidelines and Global Initiative for Asthma (GINA) 2023. * Blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months. * Patients with history ≥ 1 exacerbation the previous year under the treatment of high dose of inhaled corticosteroid(ICS)+LABA±LAMA or receiving oral/systemic corticosteroids at least 3 days. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days. * Meet requirements for biologic therapy with Benralizumab. Exclusion Criteria: * Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit. * Prior use of other biologics that has potential to interfere/ affect disease progression. * Pregnant or nursing women, or women of child-bearing potential. * History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician. * Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis).

Treatments Being Tested

DRUG

Benralizumab 30 mg/ml

Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks

Locations (1)

Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital
Thessaloniki, Greece